1. Field of the Invention
The present invention relates to a dosage form for hormonal contraception containing a given number of hormone-containing daily units and a given number of hormone-free daily units for uninterrupted daily oral administration to women, characterized in that the hormone-containing daily units contain folic acid in a daily amount of at most 200 μg and the hormone-free daily units in each case contain folic acid in a daily amount of >200 μg up to the maximum permissible amount of folic acid for women.
It is suspected that long-term taking of gestagen-based hormonal contraceptives may lead to a deficiency of folic acid. This deficiency may lead to cardiovascular diseases, for example.
It is also known that if pregnancy occurs a short time after stopping taking such hormonal contraceptives, there is a risk that the deficiency of folic acid may lead to neural tube defects in the embryo. Since the neural tube develops in the first weeks of pregnancy, it is particularly advantageous to ensure that folic acid is taken prior to conception.
If, therefore, a woman stops taking hormonal contraceptives because she wants to have a child and she falls pregnant in the first cycle after stopping the hormonal contraceptives, it is particularly important to ensure an appropriately high level of folic acid in the period directly after stopping taking the “Pill”, as hormonal contraceptives are known.
There is therefore a need to add folic acid to hormonal contraceptives in such a way that the added folic acid is adapted to a woman's varying needs over the period during and after a tablet-taking cycle.
2. Brief Description of Related Developments
The combination of hormonal contraceptives and folic acid is already known from WO 99/53910. The amount of folic acid per daily dose of hormones merely matches the changes in a woman's folic acid requirements as she ages, and does not take account of the changes in folic acid requirements over a contraceptive-taking cycle.